Registration Dossier

Administrative data

Endpoint:
skin sensitisation, other
Type of information:
other: Expert assessment
Adequacy of study:
key study
Study period:
April 04, 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An assessment was undertaken based on a Quantitative Structure-Activity Relationship (QSAR) prediction obtained for the substance in the OECD QSAR Toolbox.

Data source

Reference
Reference Type:
other: Expert assessment
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
To determine the capacity of 2-butoxyethyl methacrylate to induce skin sensitisation, a prediction was obtained for the registered substance in the OECD Quantitative Structure-Activity Relationship (QSAR) Toolbox.
GLP compliance:
no
Type of study:
other: Expert assessment

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

In vitro / in chemico

Results
Key result
Parameter:
other: Skin sensitisation
Vehicle controls validity:
not applicable
Negative controls validity:
not applicable
Positive controls validity:
not applicable
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

2-Butoxyethyl methacrylate is not expected to induce skin sensitisation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
2-Butoxyethyl methacrylate was determined not to be a skin sensitiser according to an expert assessment based on Quantitative Structure-Activity Relationships (QSAR). Classification as a skin sensitiser is subsequently not required (CLP Regulation (EC) No 1907/2006).
Executive summary:

To determine whether 2-butoxyethyl methacrylate has the capacity to induce skin sensitisation, as assessment was undertaken as part of a weight of evidence. Available experimental date was not available in the literature for 2-butoxyethyl methacrylate and, therefore, a Quantitative Structure-Activity Relationship (QSAR) prediction was obtained in the OECD QSAR Toolbox. Based on substances belonging the chemical categories ‘Acrylates/Methacrylates’ and ‘Esters’ (US-EPA New Chemical Categories) and ‘Monoethylene glycol ethers’ (OECD HPV Chemical Categories), all attained predictions were negative and statistically significant (p < 0.05). This result is supportive of 2-butoxyethyl methacrylate having a limited capacity to induce skin sensitisation. Classification under CLP Regulation (EC) No 1907/2006 as a skin sensitiser has been concluded not to be required.